Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial… (NCT06471933) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Post Market Clinical Follow up Evaluating the Performance and Safety of Juläine(TM) on Nasolabial Fold Wrinkles
Spain, Sweden59 participantsStarted 2024-07-24
Plain-language summary
The goal of this post marketing study is to verify clincal performance and safety of CE-marked device Juläine.
The main objective is to evaluate device performance when used as intended for augmentation of shallow to deep nasolabial folds.
Participants will:
Receive 3 rounds of treatment and will be followed up for a total of 2 years.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Signed Informed Consent Form
* Male or female, ≥18 years old.
* Immune-competent individuals.
* Presenting NLF contour deficiencies with a WSRS score between 2 (shallow wrinkle) and 4 (deep wrinkle) on both the left and right side of the face.
Exclusion Criteria:
* Having received a prior facial surgery for NLF correction, and/or received any local therapeutic treatment (e.g., dermal fillers).
* Having received in the past 2 weeks any local therapeutic treatment of the face below zygomatic arch.
* Pigmentation in NLF or having a history of hypo melanosis.
* Susceptibility to keloid formation or hypertrophic scarring.
* History of a known allergic reaction (e.g., any subject allergic to lidocaine or amide anesthetics, has a history of allergy to Gram-positive bacterial protein, or known to be allergic to any of the constituents of the product: PLLA, sodium carboxymethyl cellulose, mannitol, or sodium hyaluronate).
* History of herpes eruption, or a history of malignant skin disorder, or a history of any other serious disease.
* Hemorrhagic disease or receiving anti-coagulant therapy.
* Presenting with acute inflammation, infection, or having a history of chronic or recurrent infection potentially affecting the safety or performance of the device or increasing risk for adverse events.
* Having received in the past 2 months immunosuppressant or systemic steroid therapy.
* Having any disease that may affect wound healing, such as connective tissue disorde…
What they're measuring
1
Improvement on Wrinkle Severity Rating Scale (WSRS) of at least 1 grade.